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NCT03873987 · ClinicalTrials.gov registry record · Phase 1
Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients
A Phase 1 study, sponsored by Melinta Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 102
- Enrollment target
NCT03873987 is a Phase 1 study that has completed, run by Melinta Therapeutics. The registered enrollment target is 102 participants.
The verdict
NCT03873987, a Phase 1 study, has completed, sponsored by Melinta Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 102 participants
- Enrollment target
Study Summary
This study is being conducted to evaluate the pharmacokinetic (PK) and safety of Kimyrsa versus the approved oritavancin formulation in subjects with acute bacterial skin and skin structure infection (ABSSSI). Kimyrsa adjusts the infusion time, concentration and reconstitution/administration solutions of a single 1200 mg intravenous (IV) infusion of oritavancin
Interventions
- DRUG Kimyrsa
- DRUG Current Formulation of Oritavancin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2019-07-16 |
| Est. Completion | 2019-09-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03873987
The ClinicalTrials.gov registry entry for NCT03873987 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Melinta Therapeutics, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Kimyrsa is the first listed.
NCT03873987 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03873987 about?
NCT03873987 is a clinical study titled "Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients". This study is being conducted to evaluate the pharmacokinetic (PK) and safety of Kimyrsa versus the approved oritavancin formulation in subjects with acute bacterial skin and skin structure infection (ABSSSI). Kimyrsa adjusts the infusion time, concentration and reconstitution/administration solutio...
What is the current status of trial NCT03873987?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 102 participants. The study started on 2019-07-16. Estimated completion is 2019-09-04.
What interventions are being tested in trial NCT03873987?
The interventions under investigation include: Kimyrsa (DRUG), Current Formulation of Oritavancin (DRUG).
Who is sponsoring clinical trial NCT03873987?
This trial is sponsored by Melinta Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
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